Arctic Sun Temperature Management System
K-Number: K161602 · 2016-09-02
ApplicantMedivance, Inc.
Decision Date2016-09-02
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Arctic Sun Temperature Management System is a medical device manufactured by Medivance, Inc.. It received FDA 510(k) clearance on 2016-09-02 under approval number K161602. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Arctic Sun Temperature Management System?
Arctic Sun Temperature Management System is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Medivance, Inc.. The 510(k) number is K161602.
When was Arctic Sun Temperature Management System approved by the FDA?
Arctic Sun Temperature Management System received FDA 510(k) clearance on 2016-09-02, under approval number K161602.
What company makes Arctic Sun Temperature Management System?
Arctic Sun Temperature Management System is manufactured by Medivance, Inc..
What is the FDA product code for Arctic Sun Temperature Management System?
The FDA product code for Arctic Sun Temperature Management System is DWJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.